Drugs

FDA Delays Hereditary Angioedema NDA Decision

FDA has told KalVista Pharmaceuticals that it will not meet a 6/17 user fee review action target data for its NDA for sebetralstat, indicated for treating hereditary angioedema (HAE). The agency said the goal date would not be met due to heavy workload and limited resources, according to the company, adding that a decision on the submission would be made within four weeks. Such a delay is presumably related to recent reduction in force staff terminations at the agency.

“The FDA has not requested additional data or studies and has not raised any concerns regarding the safety, efficacy or approvability of sebetralstat,” the company says. “KalVista has addressed all prior information requests in a timely manner, and the company believes the only remaining item under FDA review is the finalization of the labeling.”

Sebetralstat is described by the company as an investigational oral plasma kallikrein inhibitor. HAE is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor protein and subsequent uncontrolled activation of the kallikrein-kinin system, it says. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome